Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ] [ Designated as safety issue: No ]

Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement.

Original Primary Outcome Measures ICMJE (submitted: June 16, 2011)

change in serum sex hormone binding globulin (SHBG) from baseline to treatment period end [ Time Frame: from day 1 (baseline) to day 84 (treatment period end) ] [ Designated as safety issue: No ]

Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ] [ Designated as safety issue: No ]

The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.

Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ] [ Designated as safety issue: No ]

The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit.

Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ] [ Designated as safety issue: No ]

The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.

Original Secondary Outcome Measures ICMJE (submitted: June 16, 2011)

change in sex hormone calculated free androgen index levels from baseline to treatment period end [ Time Frame: from day 1 (baseline) to day 84 (treatment period end) ] [ Designated as safety issue: No ]

change in serum thyroid hormone free thyroxine level from baseline to treatment period end [ Time Frame: from day 1 (baseline) to day 84 (treatment period end) ] [ Designated as safety issue: No ]

change in total cholesterol level from baseline to treatment period end [ Time Frame: from day 1 (baseline) to day 84 (treatment period end) ] [ Designated as safety issue: No ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide

Official Title ICMJE

Multicenter, Open-label, Single-arm Study to Evaluate Hormone and Lipid Levels in Male Subjects With Partial-onset Seizures After a Switch of Treatment From Carbamazepine as Adjunctive Treatment to Levetiracetam to Lacosamide as Adjunctive Treatment to Levetiracetam

Brief Summary

The purpose of the trial is to investigate whether changes in lipids and hormonal parameters can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment, while Levetiracetam treatment remains unchanged.